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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Syringe, Piston
510(k) Number K881867
Device Name NEEDLE EJECTOR
Applicant
Howard, Hills & Harsh
380 W. Lucy Ave.
Salt Lake City,  UT  84101
Applicant Contact LINDA R HILLS
Correspondent
Howard, Hills & Harsh
380 W. Lucy Ave.
Salt Lake City,  UT  84101
Correspondent Contact LINDA R HILLS
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/03/1988
Decision Date 11/22/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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